Injection Molded Spinal Implant Delivery Locking Mechanism
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Solution Overview
Problem
Current methods for inserting spinal implants involve reusable, machined devices that are costly to produce and sterilize, posing risks of contamination and infection due to complex cleaning and sterilization procedures.
Innovation Solution
The development of injection moldable implant delivery systems, including a toroidal implant body with a support structure and an inner shaft with a cam feature, allowing for secure locking and unlocking mechanisms, reducing contamination risks and costs by enabling single-use, sterile devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If machined implant insertion devices and implants are used, then they can be individually tailored to patient and procedure needs, but the manufacturing cost and sterilization cost significantly increase
Solution Approach 1:
The patent applies the disposable principle by designing implant insertion devices and implants that are intended for single-use only. These devices are manufactured using injection molding with biodegradable materials, allowing them to be discarded after one use rather than requiring expensive sterilization and reprocessing. This resolves the contradiction by providing customizable implants through injection molding while eliminating the high sterilization costs associated with reusable machined devices.
Solution Approach 2:
The patent utilizes parameter changes by transitioning from machined materials to injection-moldable biodegradable materials with specific degradation rates. By adjusting material composition and degradation parameters, the system achieves both customization for patient needs and cost-effective manufacturing through injection molding processes.
2Ease of manufacture
If machined implant insertion devices and implants are reused, then manufacturing cost per device decreases, but the risk of contamination and infection increases
Solution Approach 1:
The patent implements disposable single-use devices that are discarded after one procedure, completely eliminating contamination risks associated with reusing machined devices. The low manufacturing cost of these disposable injection-molded devices offsets the elimination of sterilization processes, resolving the contradiction between cost and reliability.
3Reliability
If complex cleaning and sterilization procedures are implemented for reusable devices, then infection risk decreases, but the complexity and cost of the procedure increases
Solution Approach 1:
The patent eliminates complex sterilization procedures entirely by using disposable devices that are discarded after single use. This resolves the contradiction by providing infection prevention through disposal rather than through complex cleaning and sterilization processes.
Solution Approach 2:
The patent extracts the sterilization step from the overall process by designing devices that do not require sterilization between uses. Instead of implementing complex sterilization procedures, the solution removes this entire step by using single-use disposable devices.
4Reliability
If injection moldable devices are used for single use, then contamination risk is eliminated, but the cost per usage increases compared to reusable devices
Solution Approach 1:
The patent makes disposable injection-molded devices cost-effective by using biodegradable materials and efficient injection molding processes. The low material and manufacturing costs of these disposable devices bring the per-usage cost below that of reusable machined devices, resolving the contradiction between contamination elimination and cost per usage.
5Productivity
If machined devices are sterilized and transported between usages, then they remain reusable, but the risk of contamination rises with each handling step
Solution Approach 1:
The patent uses disposable devices that are discarded after one use, completely eliminating the contamination risks associated with transporting and handling reusable devices between usages. The low cost of these disposable devices makes this approach economically viable, resolving the contradiction between reusability and contamination risk.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The injection moldable systems significantly lower the cost and risk of infection by eliminating the need for complex sterilization and reuse, while ensuring secure and efficient delivery of spinal implants with reduced contamination risks.
Implementation Method 1
the inner shaft is configured to rotate within the outer shaft such that the cam feature moves to the first position or the second position at the base of the outer shaft, wherein the rotation of the inner shaft is configured to transform into a linear movement of the inner shaft along a direction perpendicular to a plane of the rotation of the inner shaft tip
Data Source
AI summary
Injection-molded devices and systems for graft or other tissue delivery, methods for their single-use in delivery of an implant, and kits for their sterile delivery to a practitioner are disclosed herein. Systems for implant delivery comprise an injection moldable implant body and an insertion device comprising: an inner and outer shaft that form a locking mechanism that secures an implant body in place and releases it upon placement within a patient. Systems are configured to be manufactured by injection molding, such that they can be cost-effectively manufactured and discarded after a single use to avoid costs and risks associated with re-sterilization and cleaning, but can in some cases optionally also be manufactured by machining to be re-sterilized and reused.


